FDA.reportPublic FDA data

CorDx, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30318233593031823359CorDx, Inc.1N2027-01-015900 Windward Pkwy Alpharetta GA US 30005

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3302751311194016K262432CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid TestSCA2026-10-14
3302751515921330K253882CorDx Tyfast COVID-19 Ag Rapid Test RxQVF2026-06-01
3302751127985248K240728CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag TestQYT2024-06-21
3302751430092745K190412CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupNGL2019-03-21
3302751085009350K152590ACCU NEWS Drug Screening Test Card/Urine CupDKZ2016-04-15
3302751646134385K150063One Step hCG Pregnancy TestLCX2015-10-02
3302751060809471
3302751379043263
3302751526174219
3302751895018991

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
SCA12026-10-14
QVF12026-06-01
QYT12024-06-21
NGL12019-03-21
DKZ12016-04-15
LCX12015-10-02

PMN#